Bell PalsyNCT04412733
EFFECTİVENESS OF PULSED ULTRASOUND TREATMENT ON PATIENTS WITH BELL'S PALSY
A study testing Therapeutic Pulsed Ultrasound in people with Bell Palsy, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Bell's palsy (idiopathic facial palsy) is the most common peripheral lesion of the cranial nerves and the most common mono-neuropathy. Therapeutic ultrasound (US) is among the commonly used physical modalities for treating musculoskeletal disorders. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bell Palsy
- What is being tested?
- Therapeutic Pulsed Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 20 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years
- Clinically diagnosed as Bell's palsy by an ear nose and throat specialist.
Who cannot join
- Central nervous system pathology
- Recurrent Bell's palsy
- Diabetes mellitus
- Contraindications of ultrasound treatment
- Active infection
- Cancer
Show all 9Show fewer
- Pregnancy
- Lactation
- Open wound around application area
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, Ataşehir
About this study
Official title: EFFECTIVENESS OF PULSED ULTRASOUND TREATMENT ON PATIENT WITH BELL'S PALSY, A DOUBLE-BLIND, RANDOMİZED, PLACEBO-CONTROLLED TRIAL
Bell's palsy (idiopathic facial palsy) is the most common peripheral lesion of the cranial nerves and the most common mono-neuropathy. Therapeutic ultrasound (US) is among the commonly used physical modalities for treating musculoskeletal disorders. The effects of US are due to alteration of cell membrane activity, vascular wall permeability and facilitation of tissue healing. The aim of this study is to investigate the effect of pulsed US treatment in patients with Bell's palsy when added to superficial heating, massage and exercise therapies.
Read the detailed description
In this double -blind, randomized placebo-controlled trial, 32 patients (aged 18-65 years) diagnosed as idiopathic facial palsy with appropriate criteria were included. All patients were evaluated with motor nerve conduction studies and electromyography at 3-4 weeks after the onset of paralysis and 3 months after the treatment. Paralytic side frontalis and orbicularis oris muscles were used for electrophysiological analysis. Electrophysiological examinations were performed by an experienced electromyographer who was blind to the patient's treatments. Patients were separated into two groups as Group 1 (pulsed ultrasound therapy) and Group 2 (sham). Both groups were undergone to a conservative treatment program (20 min hot pack, massage 20 min and facial expression exercises) for 3 weeks, 5 days a week. In group 1 pulsed US treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2, duration 5 min) were applied to the paralyzed facial muscles. The patients in group 2 received exactly the same procedure as the treatment group, except that the power switch was off. All treatments were applied for 5 days a week for 3 weeks by the same 5-cm2 head US device (Enraf-Nonius Sonopuls 434) and the same physiotherapist. Patients were assessed at baseline, after last session, and 3 months after the treatment. Sunnybrook Facial Grading System, House Brackmann Facial Grading System and Facial Disability Index and electrophysiologic parameters were used for outcome evaluation.
- Conditions
- Bell Palsy
- Being tested
- Therapeutic Pulsed Ultrasound, Sham Ultrasound
- Keywords
- Bell's palsy, facial paralysis, pulsed ultrasound
- Medical subject headings
- Bell Palsy, Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Pulsed UltrasoundDevice
Patients in pulsed ultrasound group received pulsed ultrasound treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2). Pulsed ultrasound treatment were applied with 5-cm2 head Enraf-Nonius Sonopuls 434 ultrasound device.
Sham UltrasoundDevice
Control group received sham ultrasound treatment
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Ultrasound Group | Experimental | Patients in pulsed ultrasound group received pulsed ultrasound treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2 ) 5-min daily session, 5 days per weeks, for a total of 15 sessions. Receives: Device: Therapeutic Pulsed Ultrasound |
| Sham Group | Sham comparator | Control group received sham ultrasound with the same protocol. Receives: Device: Sham Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sunnybrook Facial Grading System
Sunnybrook Facial Grading System is a scale used to assess facial function, and scores range from 0 (complete paralysis) to 100 (normal facial function). This scale provides a clinical score which combines a static and dynamic assessment of facial muscles with the degree of synkinesis.
Measured: 3 months
Hause Brackman Facial Nerve Grading System
Hause Brackman Facial Nerve Grading System is based on a six-grade score ( I-VI) that offers a gross evaluation of facial motor function and also includes evaluation of sequelae.
Measured: 3 months
Facial Disability Index
Facial Disability Index evaluates the disability of individuals with Bell's Palsy by a total of 10 questions which assess physical and social limitations.
Measured: 3 months
Secondary outcomes (1)
Electrophysiologic Changes
Secondary outcome measures were changes of facial nerve latencies and amplitudes of compound muscle action potentials derived from the frontalis and orbicularis oris muscles.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 Jun 2019
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bell PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meryem Yilmaz Kaysin, MD, Principal investigator, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412733
- Sponsor's protocol ID
- meryemkaysin
- Status last verified
- May 2020
- First submitted
- 29 May 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients were separated into two groups as Group 1 (pulsed ultrasound therapy) and Group 2 (sham). Both groups were undergone to a conservative treatment program (20 min hot pack, massage 20 min and facial expression exercises) for 3 weeks, 5 days a week. In group 1 pulsed US treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2, duration 5 min) were applied to the paralyzed facial muscles. The patients in group 2 received exactly the same procedure as the treatment group, except that the power switch was off. All treatments were applied for 5 days a week for 3 weeks by the same 5-cm2 head US device (Enraf-Nonius Sonopuls 434) and the same physiotherapist. Patients were assessed at baseline, after last session, and 3 months after the treatment. Sunnybrook Facial Grading System, House Brackmann Facial Grading System and Facial Disability Index and electrophysiologic parameters were used for outcome evaluation.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS OF PULSED ULTRASOUND TREATMENT ON PATIENT WITH BELL'S PALSY, A DOUBLE-BLIND, RANDOMİZED, PLACEBO-CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT04412733
- Acronym / sponsor ID
- meryemkaysin
- Conditions
- Bell Palsy
- Keywords
- Bell's palsy, facial paralysis, pulsed ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bell's palsy (idiopathic facial palsy) is the most common peripheral lesion of the cranial nerves and the most common mono-neuropathy. Therapeutic ultrasound (US) is among the commonly used physical modalities for treating musculoskeletal disorders. The effects of US are due to alteration of cell membrane activity, vascular wall permeability and facilitation of tissue healing. The aim of this study is to investigate the effect of pulsed US treatment in patients with Bell's palsy when added to superficial heating, massage and exercise therapies.
Detailed description
In this double -blind, randomized placebo-controlled trial, 32 patients (aged 18-65 years) diagnosed as idiopathic facial palsy with appropriate criteria were included. All patients were evaluated with motor nerve conduction studies and electromyography at 3-4 weeks after the onset of paralysis and 3 months after the treatment. Paralytic side frontalis and orbicularis oris muscles were used for electrophysiological analysis. Electrophysiological examinations were performed by an experienced electromyographer who was blind to the patient's treatments. Patients were separated into two groups as Group 1 (pulsed ultrasound therapy) and Group 2 (sham). Both groups were undergone to a conservative treatment program (20 min hot pack, massage 20 min and facial expression exercises) for 3 weeks, 5 days a week. In group 1 pulsed US treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2, duration 5 min) were applied to the paralyzed facial muscles. The patients in group 2 received exactly the same procedure as the treatment group, except that the power switch was off. All treatments were applied for 5 days a week for 3 weeks by the same 5-cm2 head US device (Enraf-Nonius Sonopuls 434) and the same physiotherapist. Patients were assessed at baseline, after last session, and 3 months after the treatment. Sunnybrook Facial Grading System, House Brackmann Facial Grading System and Facial Disability Index and electrophysiologic parameters were used for outcome evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed Ultrasound Group | Experimental | Device: Therapeutic Pulsed UltrasoundPatients in pulsed ultrasound group received pulsed ultrasound treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2 ) 5-min daily session, 5 days per weeks, for a total of 15 sessions. |
| Sham Group | Sham comparator | Device: Sham UltrasoundControl group received sham ultrasound with the same protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18-65 years
- Clinically diagnosed as Bell's palsy by an ear nose and throat specialist.
Key exclusion criteria (9 listed)
- Central nervous system pathology
- Recurrent Bell's palsy
- Diabetes mellitus
- Contraindications of ultrasound treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Pulsed UltrasoundPatients in pulsed ultrasound group received pulsed ultrasound treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2). Pulsed ultrasound treatment were applied with 5-cm2 head Enraf-Nonius Sonopuls 434 ultrasound device. | Device | Pulsed Ultrasound Group |
| Sham UltrasoundControl group received sham ultrasound treatment | Device | Sham Group |
Primary outcome
Sunnybrook Facial Grading System
Time frame: 3 months
Sunnybrook Facial Grading System is a scale used to assess facial function, and scores range from 0 (complete paralysis) to 100 (normal facial function). This scale provides a clinical score which combines a static and dynamic assessment of facial muscles with the degree of synkinesis.
Hause Brackman Facial Nerve Grading System
Time frame: 3 months
Hause Brackman Facial Nerve Grading System is based on a six-grade score ( I-VI) that offers a gross evaluation of facial motor function and also includes evaluation of sequelae.
Facial Disability Index
Time frame: 3 months
Facial Disability Index evaluates the disability of individuals with Bell's Palsy by a total of 10 questions which assess physical and social limitations.
1 secondary outcome
Electrophysiologic Changes
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Individual participant dataSharing planned: No. Patients were separated into two groups as Group 1 (pulsed ultrasound therapy) and Group 2 (sham). Both groups were undergone to a conservative treatment program (20 min hot pack, massage 20 min and facial expression exercises) for 3 weeks, 5 days a week. In group 1 pulsed US treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2, duration 5 min) were applied to the paralyzed facial muscles. The patients in group 2 received exactly the same procedure as the treatment group, except that the power switch was off. All treatments were applied for 5 days a week for 3 weeks by the same 5-cm2 head US device (Enraf-Nonius Sonopuls 434) and the same physiotherapist. Patients were assessed at baseline, after last session, and 3 months after the treatment. Sunnybrook Facial Grading System, House Brackmann Facial Grading System and Facial Disability Index and electrophysiologic parameters were used for outcome evaluation.
Related trials for Bell Palsy
Not yet recruiting
Deep-plane Facelift As A Staged Adjunct To Facial Reanimation : Functional And Aesthetic Outcomes in Comparison to Facial Reanimation Alone
Facial Palsy
RecruitingPhase 3
Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
Vestibular Schwannoma, Facial Nerve Paralysis
Recruiting
Eye-Tracking FP "A Pilot Study of the Quantitative Evaluation of the Attention Paid to Faces With Facial Palsy by the Eye-tracking Technology.
Eye-tracking, Facial Palsy
Not yet recruiting
Mindfulness in Nonflaccid Facial Paralysis
Facial Paralysis
Recruiting
Treatment for "Asymmetric Crying Facies"
Hemifacial Microsomia, Facial Nerve Paralysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meryem Yilmaz Kaysin, MD principal investigator
Fatih Sultan Mehmet Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Pulsed Ultrasound in people with Bell Palsy, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sunnybrook Facial Grading System (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.